Introduction

Head and neck cancers are one of the leading causes of morbidity and mortality in Indian population. Overall, 57.5% of global head and neck cancers (excluding esophageal cancers) occur in Asia especially in India [1]. Head and neck cancers in India account for 30% of all cancers [2].

Unlike most other organs where only resection is the sole aim of surgery, reconstruction and restoration of function are of paramount importance in the approach of head and neck cancer management. Maintaining the integrity of the upper aero-digestive tract and preserving the vital functions such as speech, mastication, and deglutition are the mainstay of reconstructive management.

In the last two decades with the advancement of microsurgical techniques, free flaps have proved to be superior to the pedicle flaps in terms of versatility, superior esthetic, and functional outcomes [3, 4]. However, they are often criticized for being associated with prolonged operating time and higher cost.

In Indian scenario, because of the cost constraints, lack of specialized infrastructure, and relatively easy learning curve, pedicle flaps like pectoralis major myocutaneous flap are still being used widely for head and neck reconstructions. As no concrete comparative data is available in Indian scenario regarding the outcome between the free and pedicle flaps in head and neck cancers, this study concentrates upon the same.

Materials and Methods

A retrospective analysis of prospectively maintained database of 781 patients with oral cavity cancers operated by the same team of onco-surgeon and plastic and reconstructive surgeons was done. The time frame of the study was from January 2014 to July2020.

Preoperative clinico-radiological evaluation was done for all patients. All underwent resection of the primary tumor, neck dissection, and appropriate reconstruction of onco-surgical defects. Patients who underwent pedicle flap reconstruction or micro-vascular reconstruction (free flaps) were included for the analysis. Patients with primary closure and local flaps were excluded from the analysis. The type of reconstruction for defects was divided as follows:

  1. A.

    For posterior segmental mandibulectomy defects (condyle sacrificed) or buccal mucosa composite resections, reconstruction was done using either a pectoralis major myocutaneous (PMMC) flap or free anterolateral thigh (FALT) flap.

  2. B.

    For middle third segmental mandibulectomy defects/segmental mandibulectomy defects (where condyle was preserved), free fibula flap (FFOCF) was used for reconstruction.

  3. C.

    For maxillary tumors or upper gingivobuccal sulcus tumors, reconstruction was done using ALT flap or PMMC flap.

In order to minimize selection bias and make the interventions more evenly comparable with respect to bony defects, it was decided to additionally compare PMMC with FALT since both flaps were used for similar indications.

Complications, re-exploration, and flap-related mortality data were noted with the respective event dates. Complications were classified using the widely accepted Clavien–Dindo classification system [5]. Comorbidity variables of all patients were stratified using the Charlson Comorbidity Index (CCI) [6]. All patients were closely followed up peri-operatively for the 1st month and every 3 months thereafter for 2 years.

Prognostic variables were analyzed using the log rank test for univariate analysis and Cox proportional hazard for multivariate analysis. p values < 0.05 were considered statistically significant. Graphical assessment of data and all calculations were performed using SPSS 20 (SPSS Inc., 233, Chicago, IL, USA) software.

Results

The prospectively maintained database of 781 patients with OCSCC was analyzed. Overall, 628 patients had reconstruction with various flaps and 153 patients had primary closure or local rotational flap for reconstruction of defects. These 153 patients were excluded from the present analysis. The median age of the cohort was 49 years (range 17–85 years). The majority of patients were in stage III/IV (571, 90%) (Table 1).

Table 1 Baseline characteristics
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Pedicle flaps were performed in nearly 147 patients of which pectoralis major myocutaneous (PMMC) flap was done in 134 (91%) patients and 13 (9%) patients underwent pectoralis major myofascial (PMMF) flap.

A total of 481 patients had free flap reconstruction; among those, free anterolateral thigh (FALT) flap was done for 313, free radial artery forearm flap (FRAFF) was done for 77, and free fibula osseo-cutaneous flap (FFOCF) was done in 91 patients (see Table 2 for details).

Table 2 Reconstruction types
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To minimize selection bias and for more even comparison between interventions, we have additionally compared only PMMC and FALT for bony defects (posterior segmental mandibulectomy and buccal mucosa composite resections) (Table 4).

Post-operative events/complications were classified according to the Clavien–Dindo classification.

A total of 55 surgical events were noted of which there were no intra-operative events (see Tables 3 and 4).

Table 3 Complications
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Table 4 Clavien–Dindo classification complications
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Major flap failure was defined as complete flap loss. Among free and pedicle flaps, 14 (2.8%) and 1 (1%) respectively had major flap failures. In addition, 11 patients each in both group needed re-exploration for partial flap failure. Those with minor complications in free flaps were 27 (3.7%) and for pedicle flaps were 14 (8.2%). The events were analyzed with CCI score and age in both groups. In the free flap group, CCI score > 4 was associated with higher events (p = 0.02), while in the pedicle flap group, it was not significant (p = 0.29). Age (< 60 years and > 60 years) was not a significant factor associated with morbidity in both groups. Donor site morbidity was equivocal between the two groups with not much difference in the rate of infection, dehiscence, and hematoma. The quality of life measurement with respect to donor site morbidity was not assessed.

The hospital stay was recorded as ICU stay and hospital stay in both the groups. The median ICU stay in the free flap category was 2 days and 1 day in the pedicle flap group. The decannulation of tracheostomy tube in appropriate cases was also documented and reported for both groups: 7 days in the free flap group and 9 days in the pedicle flap group (range 5–18 days).

The median follow-up was of 17 months (range 1–62 months). There was no significant difference between the two groups in terms of treatment delay (> 6 weeks to start adjuvant treatment as and when required). The adjuvant treatment was not delayed in either group after surgery.

Comparison between pedicle group and FALT is given in Table 5.

Table 5 Comparison between PMMC and FALT
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Cost benefit analysis was not performed for either group though it was recorded that the average cost of the surgical procedure was higher in the micro-vascular group compared to that in the pedicle group.

Discussion

Head and neck onco-surgical resection leads to a variety of complex three-dimensional defects demanding a religious planning of the reconstructive techniques. Unlike the initial days when pedicled flaps were the lynchpin of reconstruction, surgeons now are leaning more towards the micro-vascular free flap technique which has emerged as the gold standard for reconstruction. Where the basic principle of reconstruction remains the same, i.e., esthetics, integrity, and functionality, the relevance of pedicled flaps in this era of free flap techniques should be discussed with quantified data.

Ironically in India where Sushruta in the sixth century B.C described the first reconstructive procedure of nose with forehead and cheek skin transfer [7], to date the infrastructural paucity often stagnates the optimal planning of reconstruction in head and neck cancer. The purpose of this study is to compare the differences, if any, between the outcome of free and pedicled flaps in Indian scenario, therefore shedding a light on the ideal selection of reconstruction.

There is no standard parameter defined for assessment of the outcome of any flap. While reviewing the data of other authors, it should be kept in mind that there is variability in the interpretation of complications between different centers and studies. In order to minimize this, in our study, we have used the widely accepted Clavien–Dindo classification as a standardized grading method for reporting complications.

Urken et al. had described a 93.5% success rate in a study of 200 consecutive free flaps for head and neck defects [8]. Others have reported complication rates of 10.1 [6] to 34% [9] for free flaps. In our study, we have found free flap complication rates to be around 9.7% which is equivalent to large centers with established micro-vascular reconstruction protocols [10].

Pedicled flap complication rates in different studies range from 9.6 [8] to 63.1% [7]. We found pedicled flap complications rates around 12% which is on the lower side when compared to the literature.

Allison Lee McCrory et al. [11] in their study found the average ICU stay for free and pedicled flap patients was 1.4 days and 0.1 day respectively and overall complication rates were 35% and 32%. In our study, the average ICU stay for free flaps was 2 days and 1 day in pedicled flaps, and prolonged ICU stay was seen in 1% in both free and pedicled flap cases. The decannulation for both groups was recorded which on average was earlier for patients with free flap owing to quicker healing and better support for tongue and masticatory muscles when bony reconstruction was performed. The removal of nasogastric tube was not considered one of the parameters for comparison, keeping in mind that nearly all patients underwent adjuvant treatment in the form of radiation/chemoradiation therapy and feeding tube was kept depending on severity of radiation-induced mucositis.

Medical complications as described by other authors among free flap patients range from 20.6 [12] to 29.3% [11] in which cardiopulmonary events were predominant. Medical complication in pedicled flaps as described by Allison Lee McCrory et al. [11] is 20% which was much higher as compared to our outcomes for similar group. In our study, post-operative medical complications were seen in 1.4% of patients with free and pedicle flaps.

Serletti et al. [13], in their series of 104 free flap procedures in patients aged ≥ 65 years, observed that free flaps in elderly patients had similar success rate to those of the general population and concluded that age alone should not be considered a risk factor. Other authors have also concluded that pre-existing co-morbidities and general condition of the patient, not chronological age, are more significant for free flap complications [14,15,16,17], (our comorbidity paper). Yet some authors have described age to be an individual risk factor [18, 19]. In our study, we have found there was no significant correlation with regard to complications in patients with age > 60 or < 60 year but higher CCI score was significantly associated with poorer outcomes.

Howard et al. [20] observed in their study of 197 elderly patients with free flaps that overall complication of 45.8% was seen in patients with Charlson Comorbidity Index (CCI) score > 3. In our study, we documented that CCI score > 4 was significant in predicting outcomes in free flap group. This makes a strong point to develop a comorbidity index to use in preoperative planning in patients with OCSCC.

The strength of the present study was uniform treatment protocol, consecutive patient series, same onco-surgical and plastic reconstructive team, and good follow-up for all patients. Our study is one of the largest studies reporting clinical outcomes of free flaps and pedicle flaps in recent years. The limitations of the present analysis include lack of formal quality of life evaluation and cost benefit analysis, which could possibly alter the outcomes of the study considerably. Also, we have analyzed surgical outcomes in the immediate post-operative period; post-radiotherapy effects and outcomes have not been included in this paper. Our future work will include a formal assessment of quality of life and cost benefit analysis comparing the two groups.

Conclusion

The success of any reconstruction necessitates proper pre-operative planning and evaluation of the patients and choice of reconstructive technique should be devised according to their co-morbidities, site of lesion, and other various factors. With proper planning and technical expertise, both free and pedicled flaps can provide great esthetic and functional outcome, hence improving the quality of life.